Inactive Total Small Business Set-Aside (FAR 19.5)

The National Institutes of Health (NIH) National Cancer Institute (NCI), Division of Cancer Prevention (DCP) has over 40 active clinical trials, 15 trials in development and is the sponsor for approxi... The National Institutes of Health (NIH) National Cancer Institute (NCI), Division of Cancer Prevention (DCP) has over 40 active clinical trials, 15 trials in development and is the sponsor for approximately 35 INDs (Investigational New Drug Applications). The mission of DCP is to plan and direct cancer prevention research, including testing promising agents in human clinical trials as part of a drug development program. Such testing falls under the purview of regulatory agencies such as the FDA and requires certain documentation for the use of the investigational agent. The collection, preparation, submission and continual update of this documentation is the focus of this acquisition. The purpose of this acquisition is to provide a variety of information management functions necessary to support the identification, development, and qualification of potential cancer preventive agents for investigational new drug (IND) applications to the Food and Drug Administration (FDA) for clinical trials. The proposed acquisition will involve the following type of activities, further defined in the attached draft Statement of Work (SOW Attachment 1): 1) Task Area 1: Cancer Preventive Agent Identification, Documentation, and Prioritization 2) Task Area 2: Cancer Preventive Agent Data and Report Analysis, Status and Documentation (PRECLINICAL) 3) Task Area 3: Cancer Preventive Agent Data and Report Analysis, Status and Documentation (CLINICAL) 4) Task Area 4: Information Management System 5) General Tasks in support of DCP related to the SOW requirements